PVDNCT01420289
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
A study testing High pressure intermittent pneumatic compression (HPIPC) and Excercise in people with PVD and Arterial Ulcers, run by Calvary Hospital, Bronx, NY at 1 site in United States.
Trial summary
To evaluate the effects of HPIPC for the treatment of symptoms of PAD Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- PVD, Arterial Ulcers
- What is being tested?
- High pressure intermittent pneumatic compression (HPIPC) and Excercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intermittent claudication >6mo
- Ischemic ulceration or ulcer of mixed (venous) etiology
- ABI < 0.7
- Ambulatory
- Able to comply
Who cannot join
- Gangrene
- M.I. within 6mo
- Inability to walk
- Wound infection
- Systemic corticosteroids
- HBO, Apligraf, Dermagraft within 6mo
- Falsely elevated ankle to brachial index (ABI)
- Inflammatory condition affecting healing
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Curative and Palliative wound Care, Calvary Hospital
The Bronx, New York, 10461
About this study
Official title: A Randomized, Controlled Trial to Evaluate High Pressure Rapid Sequence, Intermittent Pneumatic Compression (HPIPC) for the Treatment of Intermittent Claudication, Pain and Ulcer Healing in Subjects With PAD
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
- Conditions
- PVD, Arterial Ulcers
- Being tested
- High pressure intermittent pneumatic compression (HPIPC), Excercise
- Keywords
- Ischemic ulcers, PAD, Intermittent Claudication Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High pressure intermittent pneumatic compression (HPIPC)Device
Also called Bio Arterial Plus, Art Assist
Apply therapy for 45 minutes twice daily
ExcerciseBehavioural
Also called Walking on a treadmill
Treadmill walking 45 minutes once daily
| Study group | Role | What they receive |
|---|---|---|
| HPIPC | Experimental | High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily Receives: Device: High pressure intermittent pneumatic compression (HPIPC) |
| Excercise | Active comparator | Walking on a graded treadmill for 45 minutes once daily Receives: Behavioral: Excercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Reduction in Wound Surface Area
Measured: baseline and 16 weeks
Secondary outcomes (3)
Percent Improvement in Peak Walking Time
Percentage Improvement in the amount of time one can walk without pain
Measured: 16 weeks
Perceived Improvement in Physical Function After 16 Weeks
Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16.
The higher the score on the SF-36 questionnaire the better the QOL.
Measured: 16 weeks
Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.
Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PVDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calvary Hospital, Bronx, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
- Investigators
- Oscar M Alvarez, PhD, Principal investigator, Director Wound Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420289
- Sponsor's protocol ID
- 01-HPIPC-09
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 9 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Evaluate High Pressure Rapid Sequence, Intermittent Pneumatic Compression (HPIPC) for the Treatment of Intermittent Claudication, Pain and Ulcer Healing in Subjects With PAD
- ClinicalTrials.gov ID
- NCT01420289
- Acronym / sponsor ID
- 01-HPIPC-09
- Conditions
- PVD, Arterial Ulcers
- Keywords
- Ischemic ulcers, PAD, Intermittent Claudication Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Calvary Hospital, Bronx, NYUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Posted 9 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPIPC | Experimental | Device: High pressure intermittent pneumatic compression (HPIPC)High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily |
| Excercise | Active comparator | Behavioral: ExcerciseWalking on a graded treadmill for 45 minutes once daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intermittent claudication >6mo
- Ischemic ulceration or ulcer of mixed (venous) etiology
- ABI < 0.7
- Ambulatory
- Able to comply
Key exclusion criteria (8 listed)
- Gangrene
- M.I. within 6mo
- Inability to walk
- Wound infection
- Systemic corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High pressure intermittent pneumatic compression (HPIPC)Also: Bio Arterial Plus, Art AssistApply therapy for 45 minutes twice daily | Device | HPIPC |
| ExcerciseAlso: Walking on a treadmillTreadmill walking 45 minutes once daily | Behavioural | Excercise |
Primary outcome
Mean Percent Reduction in Wound Surface Area
Time frame: baseline and 16 weeks
3 secondary outcomes
Percent Improvement in Peak Walking Time
Time frame: 16 weeks
Perceived Improvement in Physical Function After 16 Weeks
Time frame: 16 weeks
Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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The THOR IDE Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar M Alvarez, PhD principal investigator
Director Wound Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High pressure intermittent pneumatic compression (HPIPC) and Excercise in people with PVD and Arterial Ulcers, run by Calvary Hospital, Bronx, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Reduction in Wound Surface Area (time frame: baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.